LOGO
LOGO

Slide Shows

Biotech Stocks Facing FDA Decision In January 2021

Amgen
Amgen

Amgen Inc.’s (AMGN) Nplate, which is effective in boosting the production of platelets (blood-clotting cells) in the body, awaits the FDA decision on January 28, 2021, for the proposed indication of Hematopoietic Syndrome of Acute Radiation Syndrome.

Acute Radiation Syndrome, also known as radiation toxicity, is an acute illness caused by irradiation of the entire body (or most of the body) by a high dose of penetrating radiation in a very short period of time (usually a matter of minutes).

Hematopoietic Syndrome, one of the three subtypes of Acute Radiation Syndrome, is usually caused by a radiation dose between 0.7 and 10 Gy, though mild symptoms may occur as low as 0.3 Gy, with the onset occurring 1 hour to 2 days after exposure. Anorexia, nausea and vomiting are some of the symptoms of Hematopoietic Syndrome of Acute Radiation Syndrome. (Gy or Gray is a unit used to measure radiation dose).

Nplate is already approved for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura, an autoimmune disorder in which platelets are destroyed leading to poor platelet count.

In the third quarter of 2020, sales of Nplate totaled $212 million compared to $195 million in the year-ago quarter.

AMGN closed Monday’s (Dec.28, 2020) trading at $223.65, up 0.32%.